The following data is part of a premarket notification filed by Compagnie Financiere & Medicale (cf&m) with the FDA for Humerus Wires.
| Device ID | K964243 |
| 510k Number | K964243 |
| Device Name: | HUMERUS WIRES |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | COMPAGNIE FINANCIERE & MEDICALE (CF&M) 13 BOULEVARD VICTOR HUGO Bourge-en-bresse, FR 01000 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson COMPAGNIE FINANCIERE & MEDICALE (CF&M) 13 BOULEVARD VICTOR HUGO Bourge-en-bresse, FR 01000 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-24 |
| Decision Date | 1996-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037310816 | K964243 | 000 |
| 03701037310656 | K964243 | 000 |
| 03701037310663 | K964243 | 000 |
| 03701037310670 | K964243 | 000 |
| 03701037310687 | K964243 | 000 |
| 03701037310694 | K964243 | 000 |
| 03701037310700 | K964243 | 000 |
| 03701037310717 | K964243 | 000 |
| 03701037310724 | K964243 | 000 |
| 03701037310731 | K964243 | 000 |
| 03701037310748 | K964243 | 000 |
| 03701037310755 | K964243 | 000 |
| 03701037310762 | K964243 | 000 |
| 03701037310779 | K964243 | 000 |
| 03701037310786 | K964243 | 000 |
| 03701037310793 | K964243 | 000 |
| 03701037310809 | K964243 | 000 |
| 03701037310649 | K964243 | 000 |